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FDA 510(k)

Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241

K-Number: K210937 · 2022-05-12

Decision Date2022-05-12
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241 is the device name listed in this FDA 510(k) record. The listed applicant is Alicn Medical Shenzhen, Inc.. It received FDA 510(k) clearance on 2022-05-12 under 510(k) number K210937. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241?

Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241 is a medical device that received FDA 510(k) clearance on 2022-05-12. The listed applicant is Alicn Medical Shenzhen, Inc.. The 510(k) number is K210937.

When did Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241 receive FDA 510(k) clearance?

Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241 received FDA 510(k) clearance on 2022-05-12, under 510(k) number K210937.

Who is the listed applicant for Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241?

The FDA 510(k) record lists Alicn Medical Shenzhen, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241?

The FDA product code for Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241 is FLL.

Other records listing Alicn Medical Shenzhen, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 13 devices →

Related Devices (Code: FLL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.